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Allergy to Egg | Basophil Activation Test (BAT) Sensitivity in Child Food Allergy

Allergy to Egg research study

What is the primary objective of this study?

Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common. Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision. Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis. New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial. In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.

Who is eligible to participate?

Inclusion Criteria: - Child older than 6 months and less than 18 years old - Diagnosis of type I allergy to peanut or egg - oral provocation test to peanut or egg programmed Exclusion Criteria: - No possibility to assess blood sample

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Allergy to Egg

Allergy to Peanut

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Basophil Activation Testblood sample for Basophil Activation Test

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Child food allergy suspicionBasophil Activation Test realized in case of Child food egg and peanut allergy suspicion

Study Status

Recruiting

Start Date: September 2013

Completed Date: September 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Sensitivity of the Basophil Activation Test

Secondary Outcome: Evaluation of the proportion of child positive to the BAT

Study sponsors, principal investigator, and references

Principal Investigator: Laure COUDERC, Dr

Lead Sponsor: University Hospital, Rouen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01966640

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